A Flurry of Drug Approvals by the F.D.A.

By MILT FREUDENHEIM

Published: January 1, 1992

Tying its record for new drug approvals in a single year, the Food and Drug Administration said late yesterday that it had approved four new drugs this week, bringing the 1991 total to 30. The list included Zoloft, a Pfizer treatment for depression that analysts predicted would have $1 billion in worldwide sales by 1995.

Working late on New Year's Eve, F.D.A. officials also approved two antibiotics, Eli Lilly's Lorabid, and Warner-Lambert's Penetrex, as well as Ismo, a chest-pain treatment made by American Home Products. Analysts predicted that even bigger sales would come from Zocor, a Merck & Company treatment to reduce cholesterol levels, which was approved last week; they foresaw global sales of $1.5 billion.

Also approved last week were SmithKline Beecham's Relafen, a nonsteroid arthritis treatment; Bristol-Myers Squibb's Cefzil, an antibiotic, and Johnson & Johnson's Supprelin to treat premature puberty in young children.

The eight approvals topped off a year in which the Federal agency's 30 approvals equaled the 1985 approval total -- which had been the record year since the agency began keeping an annual tally in the early 60's. In 1990, 23 were approved.

The agency said it had substantially reduced the approval time for new drug applications. The median time for new drugs approved this year was 22 months, compared with 24 months in 1990 and 29 in 1989.

Analysts and industry spokesmen praised Dr. David Kessler, who became Food and Drug Commissioner in October 1990. "He has truly lit a fire under the F.D.A.," said Neil B. Sweig, a drug analyst with Brenner Securities.

Jeffrey W. Trewhitt, a spokesman for the Pharmaceutical Manufacturers Association, a trade group in Washington, said the F.D.A. was "headed in the right direction with respect to drug approvals."

In a telephone interview, Dr. Kessler said the agency was already "streamlining" the approval process before he was appointed and that it would be making more changes to try to comply with the six-month Congressional limit for F.D.A. action, particularly for drugs for lethal diseases.

He noted that a Bristol-Myers AIDS drug known as DDI, was approved in October, only 6.2 months after the application was submitted. He added that the average approval time for cancer treatments had been about 12 months for several years.

"We are not going to be a bottleneck," Dr. Kessler said.

Commenting on recent proposals by the White House Competitiveness Council, Dr. Kessler said he had rejected a council idea that would have let drug companies choose and pay scientists to review new drugs.

But he said the agency would begin trying a council proposal to use outsiders, and would supervise private reviews of 8 to 12 drugs in "areas where we have a backlog" like arthritis and lung disease. Only drugs in a backlog will participate in such private reviews. "We retain the decision-making," he added.

Other major new drugs approved this year included Glaxo's Zofran to prevent nausea during cancer chemotherapy, and Bristol-Myers's Pravachol to lower cholesterol levels. Analysts said both would be in the billion-dollar category.

Analysts also said that two of the recently approved drugs, Lorabid and Penetrex, would have at least $200 million in global sales by 1995, as would American Home Products' arthritis drug Lodine; three blood pressure treatments -- Bristol-Myers's Monopril, Ciba-Geigy's Lotensin and Merck's Plendil -- Syntex's Ticlid for stroke patients, and an Abbott Laboratories' antibiotic, Biaxin.

Zithromax, a Pfizer antibiotic that was approved Nov. 1, will be delayed because the company had omitted information on 19 pneumonia patients, including four who later died from complications of the disease, Pfizer said. 'Best Is Yet to Come'

Sam Isaly, an analyst with Mehta & Isaly Worldwide Pharmaceutical Research in New York, projected Zithromax would have worldwide sales of $600 million, split evenly between Pfizer and a Yugoslav company, Pliva.

"It's been a great year for new drug approvals," Mr. Isaly said. "Unlike many of the 1991 drugs, which were "based on old technologies," he said, "Zofran, Zoloft and Zithromax involved really novel technology." And other new approaches are in the test stage. "The best is yet to come," he said.

The 30 new chemical entities that have been approved do not include new systems for delivering brand-name drugs like the one-a-day capsule form of Marion Merrell Dow's blood-pressure drug Cardizem, also approved this week by the F.D.A. The company got exclusive rights for three years to sell the new version of Cardizem, which had $900 million in 1991 sales.

The F.D.A. will report later on new vaccines, drugs based on natural components, those that are genetically engineered and generic versions of products on which patent protection has expired.